Clearance Summary
SL-100 ND:YAG LASER FOR UROLOGIC SURGERY received FDA 510(k) clearance under submission number K871516, sponsored by Medical Energy, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1987-07-09.
- Submission: K871516
- Applicant / Sponsor: Medical Energy, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1987-07-09
Classification & Regulation
This clearance is catalogued under FDA product code LNK and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.